A Phase II Trial of Complete Surgical Resection For Stage IV Melanoma -- Surgical Resection With Biological Evaluation and Clinical Follow-Up
Surgery
Neoplasias+5
+ Neoplasias por tipo histológico
+ Neoplasias por Sitio
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de noviembre de 1996
Fecha en la que se inscribió al primer participante.OBJECTIVES: Assess overall and progression-free survival in patients with metastatic melanoma (beyond the draining lymph nodes) after complete surgical resection of all known disease. Determine the ability of the Southwest Oncology Group Melanoma Committee to enroll patients with metastatic melanoma who can be resected to a disease-free state. OUTLINE: This is a multicenter study. All patients undergo gross total resection of all known disease. Patients whose disease cannot be completely resected or who have disease recurrence after surgery are removed from study. Patients found to have microscopic residual disease after surgery are considered completely resected. Resected tissue is submitted for analysis on protocol SWOG-9431. Patients may receive any adjuvant therapy (e.g., radiotherapy, interferon, and/or vaccines) deemed clinically appropriate by the treating physician. Patients are followed periodically for 5 years after study entry. PROJECTED ACCRUAL: A total of 100 eligible patients with completely surgically resected disease will be accrued for this study.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 77 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
DISEASE CHARACTERISTICS: Histologically confirmed metastatic melanoma that is deemed grossly surgically resectable Multiple resected sites or metastatic melanoma of unknown primary allowed provided all known disease can be grossly resected Recurrence in iliac lymph nodes after inguinal lymph dissection allowed No metastatic disease beyond the lesions planned for resection Confirmed by CT scan of chest, abdomen, pelvis, and CT or MRI of brain within 42 days of study Concurrent registration on protocol SWOG-9431 required PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer from which patient is currently disease free Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: Prior immunotherapy in the adjuvant or metastatic setting allowed Chemotherapy: Prior chemotherapy in the adjuvant or metastatic setting allowed Endocrine therapy: Prior hormonal therapy in the adjuvant or metastatic setting allowed Radiotherapy: Prior radiotherapy in the adjuvant or metastatic setting allowed Surgery: See Disease Characteristics At least 14 days since prior surgery in the adjuvant or metastatic setting Other: Recovered from prior therapy
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
Objetivos del Estudio
Objetivos Primarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 124 ubicaciones
Alaska Regional Hospital Cancer Center
Anchorage, United StatesAbrir Alaska Regional Hospital Cancer Center en Google MapsBanner Good Samaritan Medical Center
Phoenix, United StatesCCOP - Western Regional, Arizona
Phoenix, United StatesBanner Thunderbird Medical Center
Phoenix, United States